Intravascular diseases are commonly treated by relatively non-invasive techniques such as percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA). These therapeutic techniques are well known in the art and typically involve the use of guidewires, balloon catheters, and stents. In these procedures, the balloon catheter is advanced over the guidewire such that the balloon is positioned within a restriction in a diseased vessel. The balloon is then inflated and the restriction in the vessel is opened. To prevent subsequent closure of the vessel or restenosis, a physician may implant a stent. The stent is implanted through the use of a stent delivery system including a stent delivery catheter and a stent. It is desirable for the physician to receive the stent delivery catheter with the stent already positioned on the catheter so that it axially surrounds a distal portion of the catheter. When the stent is delivered in this manner, it is ready for immediate deployment.
The operating room where PTA and PTCA procedures take place is commonly referred to as a "Cath. Lab". It is desirable to have stents in a large range of sizes and styles immediately available to the physician. When the physician determines which device is needed, that device can be immediately unpackaged and used in a PTA or PTCA procedure. To assure ready access to the needed devices, it is common practice to store these devices in a supply closet in close proximity to the Cath. Lab. If a hospital has multiple Cath. Labs, the supply closet may be located in a central area accessible from all of the Cath. Labs. It is desirable that the packaging of a stent delivery assembly be designed to protect the stent and the stent delivery catheter during storage in this manner.
Each stent delivery kit is handled multiple times before it is used in a PTA or PTCA procedure, thus it is desirable to package the kit in a way which will prevent any damage to the stent or the stent delivery catheter during handling and shipment. To accomplish this, it is desirable to supply the stent delivery assembly with a covering over its distal portion to protect the stent and the stent delivery catheter from damage. This covering should be easily removable when the stent delivery assembly is unpackaged. This covering should not fall off inadvertently during shipping, handling and storage. For example, if the catheter is hung vertically when it is stored, gravity should not pull the covering off the stent delivery assembly. Ideally, the guided protector will protect the stent and the stent delivery catheter right up until the moment it is used in a PTA or PTCA procedure.
Because a wide variety of stents and stent delivery catheters may be present in a Cath. Lab, it is desirable to have different sizes and styles of stents readily identified. The packaging of the stent delivery assembly should include labeling which is clear, simple and readily visible. Ideally, this labeling will remain with the stent and the stent delivery catheter right up until the moment it is used in a PTA or PTCA procedure.